Acne VulgarisPhase 1/2NCT01556698
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
A Phase 1/2 study testing NVN1000 in people with Acne Vulgaris and Acne, run by Novan, Inc. at 1 site in Dominican Republic.
Trial summary
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris, Acne
- What is being tested?
- NVN1000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDominican Republic
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Baseline IGA score of moderate (3) or severe (4)
- Minimum of 20 but no more than 40 facial inflammatory lesions
- Minimum of 20 but not more than 60 facial non-inflammatory lesions
- No more than 2 facial nodules
Who cannot join
- Dermatological conditions on the face that could interfere with clinical evaluations
- Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
- History of experiencing significant burning or stinging when applying any facial treatment
- Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
- Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
- Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
- Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
- Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
Read the detailed description
The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.
- Conditions
- Acne Vulgaris, Acne
- Being tested
- NVN1000, Vehicle
- Keywords
- Acne Vulgaris, Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVN1000Drug
Also called Nitric Oxide 0.3%
VehicleDrug
Also called Vehicle Comparator
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NVN1000 Gel | Experimental | NVN1000 Gel topically applied one daily at bedtime for 8 weeks Receives: Drug: NVN1000 |
| Vehicle Gel | Placebo comparator | Vehicle Gel topically applied once daily at bedtime for 8 weeks Receives: Drug: Vehicle |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daisy Blanco, MD, Principal investigator, Instituto Dermatológico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556698
- Sponsor's protocol ID
- NI-AC001
- Status last verified
- Nov 2018
- First submitted
- 14 Mar 2012
- Last updated
- 19 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne
- ClinicalTrials.gov ID
- NCT01556698
- Acronym / sponsor ID
- NI-AC001
- Conditions
- Acne Vulgaris, Acne
- Keywords
- Acne Vulgaris, Acne
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novan, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
Detailed description
The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVN1000 Gel | Experimental | Drug: NVN1000NVN1000 Gel topically applied one daily at bedtime for 8 weeks |
| Vehicle Gel | Placebo comparator | Drug: VehicleVehicle Gel topically applied once daily at bedtime for 8 weeks |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Baseline IGA score of moderate (3) or severe (4)
- Minimum of 20 but no more than 40 facial inflammatory lesions
- Minimum of 20 but not more than 60 facial non-inflammatory lesions
- No more than 2 facial nodules
Key exclusion criteria (8 listed)
- Dermatological conditions on the face that could interfere with clinical evaluations
- Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
- History of experiencing significant burning or stinging when applying any facial treatment
- Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
- Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVN1000Also: Nitric Oxide 0.3% | Drug | NVN1000 Gel |
| VehicleAlso: Vehicle ComparatorPlacebo | Drug | Vehicle Gel |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daisy Blanco, MD principal investigator
Instituto Dermatológico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NVN1000 in people with Acne Vulgaris and Acne, run by Novan, Inc. at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.